RESUMO
Introduction: The consumption of ultra-processed products has been associated with the etiology of various diseases, mainly metabolic diseases. On the other hand, physical activity acts as a protective factor that helps prevent the appearance of this type of disease. In addition to the physical effects, both the consumption of ultra-processed products (UPPs) and sedentary behaviors have been associated with a significant impact on people's mental health. These problems occur significantly in university students. Online internet interventions are an alternative that has the advantage of reaching a broader sample size and adapting to various problems. Methods: A randomized controlled clinical superiority trial with two independent groups will be developed with 176 participants. Participants in both groups will be evaluated in 5 steps: (1) pretest, (2) middle of the intervention, (3) post-test, (4) follow-up at 3 months, and (5) follow-up at 6 months. In the experimental group ("UNISALUD"), participants will receive an intervention composed of 11 sessions with interactive elements such as videos, audio, and infographics created through the user experience (UX) principles and based on the health action process approach (HAPA). The participants in the control group will be on the waiting list and will receive treatment 27 days after fulfilling the inclusion criteria. Thus, participants will not receive the treatment immediately. Discussion: The study is expected to establish the feasibility of a self-help internet-based intervention created based on the user experience methodology and the health action process model, leading to a significant decrease and increase in the consumption of UPPs, ultra-healthy products, and physical activity, respectively. Conclusion: Internet-based interventions are scarce in Latin America. Due to their potential, this study will provide data about consumption of UPPs, physical activity, and mental health of the Mexican population, which will influence the reduction of health-related complications through prevention strategies or measures.Clinical Trial Registration:ClinicalTrials.gov, NCT05834842.
RESUMO
Background: Online psychological interventions have emerged as a treatment alternative because they are accessible, flexible, personalized, and available to large populations. The number of Internet interventions in Latin America is limited, as are Randomized Controlled Trials (RCTs) of their effectiveness and a few studies comparing their effectiveness in multiple countries at the same time. We have developed an online intervention, Well-being Online, which will be available to the public free of charge in 7 countries: Mexico, Ecuador, Peru, Chile, Brazil, Spain, and the Netherlands. We expect a reduction in depression and anxiety symptoms and an increase in well-being of the participants. Methods: A multi-country, randomized controlled trial will be conducted. The intervention is multicomponent (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness, Acceptance and Commitment Therapy, and Positive Psychology), with 10 sessions. In each country, eligible participants will be randomized to one of three groups: Enriched Intervention (interactive web design with videos, infographics, text, audio, and forum), Text Intervention (text on the website), and Wait List (control group). Repeated measures will be obtained at 5-time points. Our primary outcomes will be anxiety symptomatology, depressive symptomatology, and mental well-being. MANOVA analysis will be used for our main analysis. Discussion: This protocol describes the design of a randomized trial to evaluate the efficacy of a web-based intervention to reduce anxiety and depression symptomatology and increase subjective well-being. The intervention will be made available in four languages (Spanish, Portuguese, Dutch, and English). Its results will contribute to the evidence of effectiveness in terms of randomized trials and Internet interventions, mainly in Latin America and Europe.